Excellent news for Allergy Therapeutics. Allergy Therapeutics (AGY) Announces Positive Results From Grass Ph II Study. This company is interesting because AGY provides the only ultra-short course, aluminium-free treatment containing our MPL adjuvant in the European market. Further due to the dosing regimen it could be more convenient for patients. These factors AGY says is “driving market penetration in all our markets”.
Allergy Therapeutics announces positive top-line results from its Grass MATA MPL
Phase II dose ranging study
– Primary endpoint met with highly statistically significant dose-response relationship established
– Optimal -Phase III dose identified –
– Phase III study due to commence in 2019
The science for this product makes sense and an important milestone for the company allowing it to step to the phase III trials.
AGY provide uses Grass Modified Allergen Tyrosine Absorbed (MATA) MPL and it’s aim was also to find a Phase II dose range which could then be used for the phase III work(G205).
The trial met its primary endpoint of establishing a dose-response relationship and a Phase III dose.
The key results announced today:
· Primary endpoint of the trial met with highly statistically significant dose-response relationship (p<0.0001)
· All dosing regimens were safe and well tolerated
· The currently marketed product showed a significant improvement compared to placebo (p<0.01)
· Significant increase in immunoglobulin results, highly consistent with the dose response observed for the primary endpoint
· Adherence to the short treatment course was excellent. More than 95% of patients received the target cumulative dose during six weekly subcutaneous injections
The G205 trial is a multi-centre, double-blind, placebo controlled study designed to explore the safety and response of different cumulative doses of Grass MATA and MPL for grass-pollen induced seasonal allergic rhinitis. The European study took place in Germany, Poland and Austria and 447 patients were randomised into four active arms plus a placebo, evaluating the change in allergic symptoms as determined by the total symptom score (TSS) following conjunctival provocation test (CPT) with the objective to achieve a dose recommended for Phase III development.
Manuel Llobet, CEO at Allergy Therapeutics, stated that this success bring AGY closer towards marketing authorisation in the estimated $2bn US allergy market, a significant opportunity where our product has the potential to be the first registered subcutaneous immunotherapy for the treatment of grass allergy.
With an optimal dose identified, we look forward to sharing this new, exciting data with the health authorities and plan to commence a Phase III study in 2019.